An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry

Completed

• Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin detemir; Drug: other injectable antidiabetic treatment regimens

• Registration Number: NCT01892319
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe and Asia. The purpose of the study (Diabetes Pregnancy Registry) is to evaluate the safety of treatment with insulin detemir in pregnant women with diabetes mellitus.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-27
• Study First Submitted QC: 2013-07-03
• Study First Posted: 2013-07-04
• Study Start: 2013-09-30
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-18
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2446

Inclusion Criteria

• Informed consent obtained before any data collection - Woman with a positive pregnancy test - Diabetes mellitus type 1 or 2, diagnosed prior to conception - Currently treated with Levemir® or other injectable antidiabetic treatment(s) - Unchanged basal insulin or other injectable antidiabetic treatment product (for those not treated with basal insulin) 4 weeks prior to and following conception

Exclusion Criteria

• Women who have been pregnant for more than 16 weeks at baseline visit will be excluded from the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients	other injectable antidiabetic treatment regimens	-
All patients	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
Proportion of pregnancies (Levemir® treatment), compared to pregnancies (other basal insulin treatment regimens), resulting in none of the following events: Major congenital malformations, Perinatal death, Neonatal death	Assessed up to 4 weeks after delivery

Secondary Outcome Measures

Name	Time	Method
Proportion of pregnancies resulting in perinatal death	Assessed 1 week after delivery
Proportion of pregnancies resulting in pre-term delivery	Assessed at delivery
Proportion of pregnancies complicated by pre-eclampsia	During pregnancy
Height	At the age of 1 year
Incidence of major hypoglycaemia	During pregnancy
Proportion of pregnancies resulting in neonatal death	Assessed 4 weeks after delivery
Proportion of pregnancies resulting in spontaneous abortion	Assessed at pregnancy termination
Weight	At the age of 1 year
Proportion with changes (progression/regression) of major congenital malformations	At the age of 1 year

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Stevenage, United Kingdom